Albireo Pharma (ALBO) Granted FDA Fast Track Designation for A4250

Albireo Pharma (ALBO) Granted FDA Fast Track Designation for A4250

Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here. Albireo Pharma, Inc. (NASDAQ: ALBO) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to lead product candidate A4250, an ileal bile acid transporter inhibitor, which is being developed for the treatment […]

Eiger BioPharmaceuticals Announces Phase 2 ULTRA Results of Ubenimex in Lower Leg Lymphedema: Study Did …

Eiger BioPharmaceuticals Announces Phase 2 ULTRA Results of Ubenimex in Lower Leg Lymphedema: Study Did …

PALO ALTO, Calif., Oct. 16, 2018 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, today announced Phase 2 ULTRA study results in primary and secondary lymphedema of the lower limb demonstrated no improvement of ubenimex over placebo in the primary endpoint of skin thickness and […]

NDA Submitted for Dry Eye Disease Treatment KPI-121 0.25%

NDA Submitted for Dry Eye Disease Treatment KPI-121 0.25%

KPI-121 0.25% uses Kala’s AMPPLIFY mucus-penetrating particle drug delivery technology Kala Pharmaceuticals has submitted a New Drug Application (NDA) for KPI-121 0.25%, a topical product candidate for the temporary relief of the signs and symptoms of dry eye disease. The product was developed using Kala’s AMPPLIFY mucus-penetrating particle drug delivery technology, which in preclinical trials, […]

Success and Failure in Small Molecule Drug Development

Success and Failure in Small Molecule Drug Development

Case Study: Thalidomide The story begins in 1956, when a baby girl without ears was born on Christmas Day, to a mother who had taken some samples of what was said to be the world’s first safe sleeping pill, brought to her by her husband (an employee of ChemieGrünenthal) to relieve her morning sickness. molekuul_be […]

Recon: FDA Approves Pfizer's Talazoparib; Humira Biosimilars Launch in Europe

Recon: FDA Approves Pfizer's Talazoparib; Humira Biosimilars Launch in Europe

Posted 16 October 2018 | By Michael Mezher  Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Pfizer’s talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer (FDA) Drugmakers Funnel Millions To Lawmakers; A Few Dozen Get $100,000-Plus (KHN) Trump Rule Would Compel […]

Galera Therapeutics Announces Dosing of First Patient in Pivotal Phase 3 'ROMAN' Clinical Trial of Avasopasem …

Galera Therapeutics Announces Dosing of First Patient in Pivotal Phase 3 'ROMAN' Clinical Trial of Avasopasem …

Data from pivotal trial of avasopasem manganese for the reduction of severe oral mucositis in patients with head and neck cancer intended to support New Drug Application MALVERN, Pa., Oct. 16, 2018 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc., a clinical-stage biotechnology company focused on the development of drugs targeting oxygen metabolic pathways with the potential […]

Innovus Pharma receives approval from Amazon for expansion in Japan

Innovus Pharma receives approval from Amazon for expansion in Japan

The additional store will increase the Company’s worldwide Amazon store presence to its first country in Asia. Innovus Pharma expects to launch its Japanese store in the first quarter of 2019. Innovus Pharmaceuticals, an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women’s […]